510(k) Report

Devices descending from K163581

103 later devices reach Navigated ELEVATE Inserter, Navigated Disc Prep Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—